Manager, Biostatistics (Contract)
Biostatistics | Santa Monica, CA | Contract
Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term, durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system’s ability to recognize and kill tumors. For more information on Kite, please visit www.kitepharma.com.
We are seeking a highly motivated individual to join our team in a contract Manager, Biostatistics position. This contract position will work with the Biostatistics team in supporting our efforts in this exciting new area of cancer immunotherapy.
The Manager, Biostatistics will be responsible for all statistical aspects within a clinical development program, including statistical input into the clinical development plan, support of translational research, design and analysis of clinical trials, interaction with regulatory authorities and key opinion leaders, and management and oversight of outsourcing partners.
Responsibilities (include but are not limited to):
- Provides statistical expertise and input to drug development programs, including the design of translational research / biomarker analysis plans, and analyses requiring advanced statistical methodologies
- Works closely with scientists in translational research and clinical development to write study protocols and design experiments, collaborate on biomarker strategy, study design, methodology, data analysis and interpretation
- Provides statistical input into the preparation of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies
- Develops and reviews statistical analysis plans, including the definitions of derived variables, the structure and content of analysis data sets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports. Authors technical reports and publications, ensures the timely delivery of top line study results.
- Ability and experience to guide data management and programming in developing standards for building databases, edit checks, and statistical programming for data analyses
- Monitors project progress and ensures proper resource allocation; performs vendor oversight for assigned programs and provides quality review of vendor deliverables
- Establishes and maintains effective working relationships with vendors and project teams
- Knowledge of advanced clinical trial design concepts and an understanding of clinical / regulatory concepts in oncology; maintains currency with developments in these fields
- Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks
- PhD in biostatistics, statistics, or mathematics
- 0- 2 years of industry experience
- Advanced and broad knowledge of statistical methods, along with understanding of industry practices related to drug development
- Excellent verbal, written, and presentation skills including the ability to clearly describe advanced statistical techniques and interpret results
- Working knowledge of SAS and / or R
Kite Pharma is an equal opportunity employer based in beautiful Santa Monica, CA. Kite Pharma offers the opportunity to be part of a successful, fast growing company in a cross functional and collaborative environment.
To learn more about us, please visit our website at www.kitepharma.com
No phone calls please and no agencies or recruiters.